[Federal Register Volume 62, Number 61 (Monday, March 31, 1997)]
[Rules and Regulations]
[Pages 15343-15344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7972]
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21 CFR Part 101
[Docket No. 95P-0197]
RIN 0910-AA19
Food Labeling: Health Claims; Soluble Fiber From Whole Oats and
Risk of Coronary Heart Disease
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
regulation that authorizes health claims about the relationship between
soluble fiber from whole oats and coronary heart disease (CHD) to
clarify and correct its provisions. This action is being taken in
response to inquiries that FDA has received since it issued this
regulation.
EFFECTIVE DATE: March 31, 1997.
FOR FURTHER INFORMATION CONTACT: Joyce J. Saltsman, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204,202-205-5483.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 23, 1997 (62 FR 3584), FDA
published a final rule announcing its decision to authorize the use of
health claims on the relationship between soluble fiber from whole oats
(i.e., oat bran, rolled oats, and whole oat flour) and the risk of CHD
(Sec. 101.81 (21 CFR 101.81)). Since then, questions have been raised
regarding the meaning of the regulation. Therefore, FDA is amending
Sec. 101.81 to correct and clarify the regulation.
II. Nature of the Claim (Sec. 101.81(c)(2)(i))
Section 101.81(c)(2)(i)(C) states that ``in specifying the
substance, the claim uses the term `soluble fiber' qualified by either
the use of the name of the eligible source of whole oat soluble fiber
(provided in paragraph (c)(2)(ii) of this section) or the name of the
food product.''
The agency is amending Sec. 101.81(c)(2)(i)(C) to clarify that the
claim must state the name of the source of eligible soluble fiber, and
that it may state the name of the food product that contains the source
of the soluble fiber. In the preamble to the whole oats final rule (62
FR 3584 at 3595), the agency gave examples of statements that complied
with Sec. 101.81(c)(2)(i)(C). Those examples were: ``Soluble fiber from
whole oats * * *'' and ``Soluble fiber from oatmeal
* * *.'' The agency stated that:
In each case, the inclusion of information about the source or
the product qualifies the term soluble fiber so that the consumer is
not misled to believe that all soluble fiber may reduce the risk of
CHD. The manufacturer may also clarify the information for those
product names that do not indicate the name of the soluble fiber
source, for instance: ``Soluble fiber from the oat bran in this
product * * *.''
62 FR 3584 at 3595
As the discussion of this provision in the final tried to make
clear, it was the agency's intention that the claim use the name of the
whole oat food, i.e., oat bran, rolled oats, or whole oat flour, that
is the source of soluble fiber, so that the consumer would not be
misled to believe that all soluble fibers that may be present in the
food may reduce the risk of CHD. However, the agency has come to
recognize that a claim such as ``Soluble fiber from Today's Cereal as
part of a diet low in saturated fat and cholesterol may reduce the risk
of heart disease,'' which does not identify the source of the soluble
fiber that provides the basis for the claim, satisfies
Sec. 101.81(c)(2)(i)(C) in that it uses the term ``soluble fiber''
qualified by the name of the product. Thus, the regulation does not set
out the rule the agency intended to embody in the regulation.
Consequently, FDA finds it necessary to amend
Sec. 101.81(c)(2)(i)(C) to make clear that the food source of the beta
()-glucan soluble fiber in the product that bears the claim
must be identified in the health claim, and that use of the product
name is optional. Therefore, in this document, the agency is correcting
Sec. 101.81(c)(2)(i)(C) to state:
In specifying the substance, the claim uses the term `soluble
fiber' qualified by the name of the eligible source of soluble fiber
(provided in paragraph (c)(2)(ii) of this section). Additionally,
the claim may use the name of the food product that contains the
eligible source of soluble fiber.
III. Nature of the Food Eligible to Bear the Claim
(Sec. 101.81(c)(2)(iii))
Section 101.81(c)(2)(iii)(A) states that, ``the food shall contain
at least 0.75 gram (g) per reference amount customarily consumed of
whole oat soluble fiber from the eligible sources listed in paragraph
(c)(2)(ii) of this section.'' Section 101.81(c)(2)(ii) lists three
whole oat foods that are eligible sources of -glucan soluble
fiber: Oat bran (Sec. 101.81(c)(2)(ii)(A)(1)), rolled oats or oatmeal
(Sec. 101.81(c)(2)(ii)(A)(2)), and whole oat flour
(Sec. 101.81(c)(2)(ii)(A)(3)).
Questions have been raised regarding whether an extract of whole
oat -glucan soluble fiber, such as an extract of -
glucan from oat bran, could be used to fortify a product and thus
qualify for the health claim.
FDA intended to make clear in Sec. 101.81 that an extract of an
eligible oat food could not justify the use of the authorized health
claim. In the preamble to the whole oat final rule, the agency stated
that the -glucan soluble fiber in whole oat products is the
primary, but not the only, component in whole oats that affects serum
lipids (62 FR 3584 at 3585). The agency also stated that:
Other food sources of -glucan soluble fiber (such as
oat gum and non-oat sources) have not been carefully reviewed by the
agency, nor has the totality of the evidence on these other sources
of the fiber been submitted to the agency for review. Thus, the
basis for including a wider range of food sources of -
glucan beyond whole oats in the regulation authorizing health claims
is not presented by the administrative record, and consideration of
these other sources is beyond the scope of this rulemaking.
62 FR 3584 at 3587
It was the agency's intention that the provisions in
Sec. 101.81(c)(2)(iii)(A) define the nature of the whole oat foods that
are eligible sources of -glucan soluble fiber, and not to
suggest that -glucan soluble fiber by itself could be used to
fortify a product for purposes of making a claim.
The inquiries that FDA has received, however, stated that FDA needs
to make its meaning even clearer in Sec. 101.81(c)(2)(iii)(A).
Therefore, in this document, the agency is amending this provision to
state: ``The food product shall include one or more of the whole oat
foods from Sec. 101.81(c)(2)(ii), and the
[[Page 15344]]
whole oat foods shall contain at least 0.75 gram (g) of soluble fiber
per reference amount customarily consumed of the food product.''
IV. Model Health Claim (Sec. 101.81(e))
In light of the revision to Sec. 101.81(c)(2)(i)(C) in section II
of this document, the agency is making minor changes to the model
claims in Sec. 101.81(e)(1) and (e)(2). In current paragraphs (e)(1)
and (e)(2) in the model claims, the name of the soluble fiber source
from Sec. 101.81(c)(2)(ii) or the name of the food product may be
provided. In this document, the agency is revising the model claims to
clarify that the name of the soluble fiber source from
Sec. 101.81(c)(2)(ii) must be presented and, if desired, the name of
the food product may also be provided. For example, FDA is amending
Sec. 101.81(e)(1) to state, ``Soluble fiber from foods such as [name of
soluble fiber source from section (c)(2)(ii) and, if desired, the name
of food product], as part of a diet low in saturated fat and
cholesterol, may reduce the risk of heart disease.'' Therefore, a claim
for an oat bran-containing food may state, ``Soluble fiber from foods
such as oat bran in Brand Name Cereal, as part of a diet low in
saturated fat and cholesterol, may reduce the risk of heart disease.''
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.81 is amended by revising paragraphs (c)(2)(i)(C),
(c)(2)(iii)(A), (e)(1), and (e)(2) to read as follows:
Sec. 101.81 Health claims: Soluble fiber from whole oats and risk of
coronary heart disease (CHD).
* * * * *
(c) * * *
(2) * * *
(i) * * *
(C) In specifying the substance, the claim uses the term ``soluble
fiber'' qualified by the name of the eligible source of soluble fiber
(provided in paragraph (c)(2)(ii) of this section). Additionally, the
claim may use the name of the food product that contains the eligible
source of soluble fiber;
* * * * *
(iii) * * *
(A) The food product shall include one or more of the whole oat
foods from paragraph (c)(2)(ii) of this section, and the whole oat
foods shall contain at least 0.75 gram (g) of soluble fiber per
reference amount customarily consumed of the food product;
* * * * *
(e) * * *
(1) Soluble fiber from foods such as [name of soluble fiber source
from paragraph (c)(2)(ii) of this section and, if desired, the name of
food product], as part of a diet low in saturated fat and cholesterol,
may reduce the risk of heart disease.
(2) Diets low in saturated fat and cholesterol that include soluble
fiber from [name of soluble fiber source from paragraph (c)(2)(ii) of
this section and, if desired, the name of food product] may reduce the
risk of heart disease.
Dated: March 25, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-7972 Filed 3-28-97; 8:45 am]
BILLING CODE 4160-01-F
